Job SummaryResponsible for ensuring customer and regulatory requirements have been met by supporting the QA Inspectors in the inspection of product and review of documentation throughout all aspects of the production process (e.g., manufacturing, filling, and labeling / assembly, etc.). Ensures compliance with all applicable standards and regulations (e.g., ISO 9001, ISO 13485, 21 CFR 820, 21 CFR 11, ISO 17025, and EXCiPACT), Good Manufacturing Practices (cGMPs), and Good Documentation Practices (GDPs). Participates as lead inspector or subject matter expert (SME) in areas such as: investigation, validation, training, and audits (e.g., internal quality system audits and line of sight / on the floor audits). Serves as back up to team lead. MAJOR JOB DUTIES AND RESPONSIBILITIES (List in order of importance)
QUALIFICATIONS (Education/Training, Experience and Certifications)
- Senior Inspector responsibility:
- Investigation - Performs real-time risk assessment and sufficiently controls suspected non‑conforming finished products, raw materials, and/or packaging components. Provides oversight to ensure appropriate segregation of non-conforming material and resolution to product to resolve customer product pipeline.
- Training - Provides initial training to new QA Inspectors; assists other departments with necessary training that pertains to functional aspects of the Quality Management System (QMS). Develops, maintains, and routinely evaluates on-boarding requirements for QA Inspectors.
- Scheduling -Assists with daily and weekend QA coverage to support production activities.
- Batch Record Review and Release - Assists with the review and release of batch records as needed to support on-time delivery; ensures GDP compliance.
- Provides coaching and mentorship to QA Inspectors, and is the initial point of contact for production issue resolution.
- Complies with company policies, procedures, work instructions, and training requirements focusing on customer service, production, and quality.
- Keeps customer interests and regulatory requirements in mind, ensures customer needs are met by reviewing order requirements, customer documentation requirements, proper filling and assembly requirements, and, where needed, ensures other technicians understand and follow documented Avantor procedures and GMP requirements.
- Ensures customer requirements are met.
- Verifies adherence to policies, procedures, and work instructions.
- Reviews production documentation for accuracy, completeness, and GDP compliance.
- Assists in correcting order issues and ensures actions that are taken are appropriate.
- Communicates issues / concerns to area owner and direct manager.
- Ensures actions taken to resolve production issues and concerns are effective.
- Ensures that the area is in a state of "audit readiness" at all times.
- Performs inspection tasks by following established work instructions and procedures, by using required tools and methods and; when applicable, equipment, to determine acceptability of product, components, and documentation.
- Performs pre-fill, in-process, and final inspections with the aid of documented work instructions and inspection information as required.
- Stops production when a non-conformance (NCM) is observed and follows appropriate NCM procedures.
- Documents non-conformances following applicable procedures and work instructions.
- Documents and trends any quality production issues discovered during the course of inspection duties.
- Ensures cleanliness of work areas during the inspection processes.
- Assists in the development and implementation of corrective and / or preventive actions.
- Adheres to QMS and Policies, where applicable.
- Performs other duties as assigned.
KNOWLEDGE SKILLS AND ABILITIES (Those necessary to perform the job competently)
- High School completion or equivalent (GED) and a minimum of 5 years related experience and/or training in a regulated industry is required; OR
- Bachelor's degree, and a minimum of 3 years related experience and/or training in a regulated industry is required
- American Society of Quality (ASQ) certifications, Certified Quality Improvement Associate (CQIA), or Certified Quality Inspector (CQI) is preferred
- Experience in a Quality Assurance role within the medical device, biotech, or pharmaceutical industry is preferred
- Must be able to balance multiple tasks and prioritize efficiently
- Knowledge of ISO 9001, ISO 13485, 21 CFR 820, 21 CFR 11 standard is preferred
- Demonstrated experience or knowledge in conducting root cause analysis as it relates to non‑conforming material investigations
ENVIRONMENTAL WORKING CONDITIONS & PHYSICAL EFFORT (Under Typical Positions)
- Knowledge and experience utilizing Microsoft Outlook, Word, Excel, and Access, or equivalent software packages
- Ability to lead others by example and provide direction
- Good communication skills
Works on the production floor with adequate lighting and ventilation with occasional elevated noise levels and a varying range of temperatures.
Work assignments are diversified. Examples of past precedent are used to resolve work problems. New alternatives may be developed to resolve problems.
A frequent volume of work and deadlines impose strain on routine basis.
Minimal physical effort is required; however, the position does require frequent walking, standing, bending, reaching, lifting or possibly carrying objects weighing up to 50 lbs.
While performing the duties of this Job, the employee is occasionally exposed to fumes or airborne particles and toxic or caustic chemicals. DISCLAIMER:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
Avantor is proud to be an equal opportunity employer. EEO StatementWe are an Equal Employment/Affirmative Action employer. We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected Veteran status, or any other characteristic protected by federal, state/province, or local law. If you need a reasonable accommodation for any part of the employment process, please contact us by email at TalentManagement@avantorsciences.comand let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.For more information about equal employment opportunity protections, please view the Equal Employment Opportunity is THE LAW Poster, EEO is the Law Poster Supplement, and Pay Transparency Non-Discrimination Provision using the links below.
EEO is the Law
OFCCP EEO Supplement
PAY TRANSPARENCY NONDISCRIMINATION PROVISION
3rd party non-solicitation policy
By submitting candidates without having been formally assigned on and contracted for a specific job requisition by Avantor, or by failing to comply with the Avantor recruitment process, you forfeit any fee on the submitted candidates, regardless of your usual terms and conditions. Avantor works with a preferred supplier list and will take the initiative to engage with recruitment agencies based on its needs and will not be accepting any form of solicitation